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Sponsored by: |
Biosense Webster, Inc. |
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Information provided by: | Biosense Webster, Inc. |
ClinicalTrials.gov Identifier: | NCT00116428 |
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. It is currently FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory Ventricular Tachycardia for MI patients. The catheter is approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Condition | Intervention | Phase |
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Heart Diseases Arrhythmia Atrial Fibrillation |
Device: NAVISTAR® THERMOCOOL® catheter |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation |
Estimated Enrollment: | 230 |
Study Start Date: | October 2004 |
This is a prospective, randomized, open-label, active-control trial that will enroll up to 230 participants at up to 30 hospitals in the U.S. Patients will be randomized using a 2:1 scheme for the test procedure (ablation)and control (medical therapy) groups, respectively. Patients who fail the trial medication may have an RF ablation procedure according to protocol.
We're trying to improve treatment for atrial fibrillation - you can help!
Do you have episodes of chest pain, palpitations or fainting? This may be due to a condition called "Paroxysmal Atrial Fibrillation". If drug therapy has not been successful to treat this condition or you have intolerable side effects due to medications you are currently taking to treat this condition, you may be eligible for this trial.
What is being studied?
This clinical trial is comparing the safety and effectiveness of a non-drug treatment (medical device) called catheter ablation with the standard drug therapy for AFib. This study is evaluating whether a particular investigational ablation catheter can be used safely and effectively to treat paroxysmal atrial fibrillation.
What does the treatment consist of?
In this procedure, thin flexible tubes (catheters) are inserted into a vein in the groin and threaded into the heart. An attachment at the tip of the catheter delivers electrical energy to the heart tissue. This results in a small, localized burn which modifies the areas of heart muscle essential for starting or maintaining the atrial fibrillation.
Is this treatment dangerous?
All interventional treatments have risks. However, this procedure is widely used for other types of heart rhythm disorders in the U.S. and worldwide with low complication rates. The treatment of paroxysmal atrial fibrillation is a new indication for this particular catheter. Which is why it is the subject of a clinical trial.
I've already failed drug therapy. Can I be in the catheter ablation treatment group?
In order to approve a new treatment, the government requires that "randomized" clinical trials be conducted, comparing the new treatment with the standard of care at the time. In this trial, approximately two-thirds of the patients will receive the ablation treatment, while the remaining patients will be given an antiarrhythmic medication. Those who receive the medication may be eligible to have the ablation treatment at a later date.
Why would I want to take part in this trial?
Currently in the U.S., AFib is primarily treated with drug therapy. But about half of patients treated with antiarrhythmic drugs fail to achieve relief from AFib or find the side effects of the drugs intolerable. The purpose of the study is to demonstrate whether catheter ablation is safe and effective for treating AFib. You would therefore be helping to advance knowledge about the treatment of patients like yourself who have AFib and who are either not getting relief from medications or are unduly bothered by the drug's side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
You may be eligible to participate in this study if you: Have failed to respond to drug treatment for your AFib, or find the side effects of your medication intolerable.
United States, Arizona | |
Arizona Arrhythmia Consultants | |
Scottsdale, Arizona, United States, 85251 | |
United States, California | |
Marin General Hospital | |
Greenbrae, California, United States, 94904 | |
United States, Florida | |
Florida Hospital | |
Orlando, Florida, United States, 32803 | |
United States, Illinois | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
United States, Kentucky | |
Central Baptist Hospital | |
Lexington, Kentucky, United States, 40503 | |
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Brigham and Women's Hospital, Cardiology Division | |
Boston, Massachusetts, United States, 02115 | |
Lahey Clinic Medical Center | |
Burlington, Massachusetts, United States, 01805 | |
United States, New York | |
St. Lukes Roosevelt Hospital | |
New York, New York, United States, 10025 | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Wake Forest University School of Medicine | |
Winston-salem, North Carolina, United States, 27157 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
Texas Cardiac Arrhythmia Research | |
Austin, Texas, United States, 78705 | |
United States, Virginia | |
Inova Fairfax Hospital | |
Falls Church, Virginia, United States, 22042 |
Study ID Numbers: | BWI03130 |
Study First Received: | June 29, 2005 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00116428 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Atrial Fibrillation Paroxysmal Atrial Fibrillation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |